Intuitive hit with FDA warning over da Vinci reports

Intuitive Surgical received a Form 483 from the FDA, citing problems with how it reported issues with da Vinci.--Courtesy of Intuitive Surgical

The FDA has chided Intuitive Surgical ($ISRG) for failing to report field corrections to the agency, saying the company warned customers about potential problems with the da Vinci surgery system but violated protocol when it didn't inform regulators.

On four occasions over the past two years, Intuitive has sent letters to customers warning of possible safety issues with da Vinci instruments and clarifying the system's indications, but not once did the company loop the FDA in its communications, the agency said. In one case, Intuitive's correction was a response to 5 adverse event reports tied to da Vinci, details the company withheld from the FDA, according to the agency.

The FDA detailed its reprimand in a Form 483, an action that doesn't carry repercussions for Intuitive but often precedes a full warning letter.

Intuitive's shares slid as much 2% on Wednesday morning, trading at around $501 by 9 a.m. ET.

The company has already amended its practices to address the FDA's concerns, detailing its actions in a June 7 letter to the agency, Communications Vice President Angela Wonson wrote in an email.

"We take our regulatory obligations seriously and have implemented corrective actions for all four observations," Wonson wrote.

With all of Intuitive's recent da Vinci trouble from shareholders, regulators and patients, another blemish for the company will attract a fair amount of attention, but Canaccord Genuity analyst Jason Mills said the letter is unlikely to portend problems down the line.

"Based on our conversations with management last night, we believe the objections listed on the Form 483 are primarily administrative in nature, do not reflect any safety concerns with the da Vinci surgical system and will not likely pose any material impact to the business," Mills said in a note to investors Wednesday.

Still, Intuitive is up against mounting litigation from patients claiming they suffered injuries because of the company's lax training programs. Intuitive won its first such case, dodging $8.5 million in damages thanks to a Washington jury, but it's still on the line for at least 25 more.

And now shareholders have gotten in on the litigation, launching a class action suit alleging that Intuitive withheld safety information on da Vinci in order to boost its stock price. Intuitive has said it believes that suit is without merit.

- read the FDA's letter (PDF)

Editor's note: This story has been updated to reflect comments from Intuitive Surgical.

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